Congratulations Hospital Sultan Abdul Halim for achieving Top Recruiter in APAC!

Malaysia is recognized as TOP RECRUITER in the Asia Pacific region and in the country for the  VALOR-CKD study. Congratulations to  Dr. Eason Chang and team at Hospital Sultan Abdul Halim for this achievement and recognition.

Establishing Clear Procedures and Improving Start-up Timeline in Malaysia’s Clinical Research Ecosystem

As delays in getting clinical trials up and running have financial implications, pharmaceutical companies and contract research organisations (CROs) are looking at ways to accelerate the study start-up process. Challenges in processes such as feasibility assessment, site selection, compilation of essential documents, submission to ethics committee, and application for investigational product import license can affect study milestones and timelines.1,2

In Malaysia, the Ministry of Health established a corporate entity, CRM, that functions as a one-stop centre to facilitate industry-sponsored research in the country to ensure an efficient start-up process. The organisation offers services such as feasibility assessment, budget negotiation, clinical trial agreement review and placement of study coordinators. This article describes CRM’s timeline in feasibility assessment, budget negotiation and clinical trial agreement review, besides the regulatory and ethics approval timeline in Malaysia.

Centralised Feasibility and Site Selection Services

The company has a centralised feasibility team that handles feasibility queries from CROs, pharmaceutical, medical device, and biotechnology companies. The feasibility team maps the sites according to disease specialities and workload, saving the time it takes to identify the right investigators and sites with interest in a particular clinical trial. It also assists interested potential investigators to address the queries and submits the completed feasibility questionnaire to the CRO or sponsor (Figure 1). Having a centralised service is far more efficient as the individual databases of the CROs and sponsors may not always be updated and sufficiently comprehensive.3 As the single point of contact, the standardised processes lead to streamlined communications which reduce delay and confusion on the ground. As a result, the turnaround time is shorter than if a sponsor or CRO were to approach individually. With CRM’s central database and feedback from the sites and investigators, a completed feasibility questionnaire can be sent back to the enquiring company within 5–10 working days (Table 1).

Prompt Review and Negotiations of Clinical Trial Contracts

The top cause of delays in clinical trial start-up time is related to contract and budget negotiations.1,4 Lack of effective communication, unclear processes, bureaucracy, and difficult to understand contracts can lengthen the time it takes to finalise the clinical trial agreements (CTAs).4,5 To address these challenges, an experienced legal and regulatory affairs department reviews and endorses CTAs (on behalf of principal investigators) for all clinical trials conducted at public hospitals in Malaysia within 14 calendar days, from the last feedback received from the party involved in the study budget negotiation (Table 1). In addition to an experienced legal team, CRM has implemented an online system for submission and internal review of CTAs to shorten the timeline for review. Prior to this, the average time to review a CTA was 59 days.

Parallel Ethics and Regulatory Approval Processes

Clinical trials that are conducted in the Ministry of Health (MOH) facilities will require ethics approval from the MREC (Medical Research and Ethics Committee), which is the sole ethics committee for Malaysia’s MOH facilities. MREC also acts as an independent ethics committee for facilities outside the MOH who do not have their own ethics committees. Malaysia’s regulatory authority for pharmaceutical trials is the National Pharmaceutical Regulatory Agency (NPRA). The NPRA is responsible for approving applications for clinical trial import licence (CTIL) and clinical trial exemption (CTX). Ethical approval is needed before the CTIL or CTX is released (Figure 1).

For medical device trials, the Medical Device Authority (MDA) oversees the issuance of the letter of no restrictions for notification of medical devices for clinical use and research supportive use. This would take 14 working days. On the other hand, notification of medical devices for clinical investigational use will go through a review by the Technical Committee of Medical Device Clinical Evaluation (TCMDCE). The issuance of a letter of no restrictions would take seven working days after evaluation by the committee. In 2019, an online system was introduced to facilitate the process.

Applications and tracking of progress are done through a local online registration of clinical studies, the National Medical Research Register (NMRR). With the NMRR being linked to the MREC, ethics approval processes are fast and convenient. An NMRR registration is also needed for CTIL/CTX application.

In Malaysia, regulatory and ethical submissions are done in parallel.6 Regulatory approval takes approximately 30 business days while MREC ethics approval takes about 50 business days7,8 (Table 1). Ethical review and approval can be as short as one month from the time of application if there are no issues/queries.8,9 On average, it takes about four months to obtain regulatory and ethics approval.10

Conclusion

Consistent timelines, reliability and efficient processes are important criteria for sponsors and CROs in deciding where to conduct its clinical trials. With CRM’s involvement at the feasibility and startup phase, as well as a standardised process for regulatory and ethics approval, sponsors will have better understanding and assurance on the timeline, processes and reliability of conducting clinical trials in Malaysia.

Audrey Ooi (Acting Head Business of Development) and Noorzaihan Mat Radi (Senior Feasibility Specialist) are from Clinical Research Malaysia.

REFERENCES

  1. Clinical Researcher. Accelerating Study Start-Up: The Key to Avoiding Trial Delays (February 1, 2017). Available at https://acrpnet.org/2017/02/01/accelerating-study-start-up-the-key-to-avoiding-trialdelays/, visited on 1 November 2019.
  2. Lamberti, M.J. Clinical Trials Take A Long Time to Get Started. Here’s How to Speed It Up (March 28, 2018). Available at https://www.statnews. com/2018/03/28/clinical-trials-startup-speed/, visited on 1 November 2019.
  3. Ooi, A.J.A & Khairul, F.K. A Unique Model to Accelerate Industry-Sponsored Research in Malaysia. Journal for Clinical Studies. 11(1), 24–27(2019).
  4. Applied Clinical Trials Editors. Clinical Trial Agreement Negotiations (June 1, 2012). Available at http://www.appliedclinicaltrialsonline.com/clinical-trial-agreement-negotiations, visited on 1 November 2019.
  5. Abdul Rahman, N.A. & Yusop, N. Evolution of Clinical Trial Agreement Review in Malaysia Through Clinical Research Malaysia. (September 21,2018). Available at http://www.appliedclinicaltrialsonline.com/evolutionclinical-trial-agreement-review-malaysia-through-clinical-researchmalaysia, visited on 1 November 2019.
  6. Malaysian Investment Development Authority. Guide on Pharmaceutical Industry in Malaysia. June 2017.
  7. Ali, S., Egunsola, O., Din Babar, Z.U. & Hasan, S.S. Challenges of Conducting Clinical Trials in Asia. Int J Clin Trials. 5(4), 194–199 (2018).
  8. Society of Clinical Research Professionals Malaysia. A Guide to Conducting Clinical Trials in Malaysia (1st edition) 2016.
  9. Burton, P. Malaysia: A Clinical Trials Hub For Southeast Asia? (November 20, 2018). Available at https://pharmaboardroom.com/articles/malaysiaa-clinical-trials-hub-for-southeast-asia/, visited on 1 November 2019.
  10. Frost & Sullivan (2016) Asia: preferred destination for clinical trials. https://novotech-cro.com/sites/default/files/170217_FrostSullivan_Asia%20white%20paper_full.pdf

Source: Journal for Clinical Studies, Volume 12 Issue 1

Malaysia starts global “Solidarity Trial” – a research effort to test possible treatments for COVID-19

PUTRAJAYA, 6th April 2020 – The “Solidarity Trial”, launched by the World Health Organization (WHO), will see Malaysia’s involvement in an international effort to test several drugs in treating COVID-19.

The WHO globally coordinated trial is an unprecedented effort to collect reliable data and compare the safety and effectiveness of four treatment protocols using different combinations of Remdesivir, Lopinavir/Ritonavir, Interferon beta, Chloroquine and Hydroxychloroquine.

The Director General of Health, Ministry of Health (MOH) Malaysia Datuk Dr Noor Hisham Abdullah said, MOH has fast-tracked the process to implement the drug trials to treat patients with COVID-19, which will begin soon. The nine MOH hospitals included are Tuanku Fauziah Hospital, Sultanah Bahiyah Hospital, Pulau Pinang Hospital, Sungai Buloh Hospital, Kuala Lumpur Hospital, Melaka Hospital, Tengku Ampuan Afzan Hospital, Sarawak General Hospital and Queen Elizabeth Hospital.

“The global pandemic is affecting more than 180 countries, and one of these drugs may be our best hope for treating people infected with COVID-19,” said Dr Ying-Ru Lo, the Head of Mission and WHO Representative to Malaysia, Brunei Darussalam and Singapore. “This is our chance, as a global community, to turn the tide against the pandemic. Malaysia will be a valued partner in this trial to evaluate potential treatments that are more effective, and to save lives in the global battle to fight this virus.”

The research will be headed by Dr Chow Ting Soo, Infectious Disease (ID) Consultant at Pulau Pinang Hospital with a team comprising of 16 ID physicians and pharmacists as Co-Investigators at the respective MOH hospitals. Director General of Health, Datuk Dr Noor Hisham Abdullah gave his assurance that the trial will adhere to all safety standards set by the National Pharmaceutical Regulatory Agency.

“Malaysia’s participation in this worldwide trial could help find life-saving medicines for COVID-19 through evaluating their safety and effectiveness,” said Datuk Dr Noor Hisham Abdullah. He added that MOH Institute for Clinical Research (ICR) and Clinical Research Malaysia (CRM) would help facilitate the implementation of the WHO-initiated trial in Malaysia.

 

Media contact :
WHO: Dr Cory Couillard, Consultant WHO Country Office in Malaysia: couillardc@who.int;  +6017 6487520
MOH Malaysia: Dr Goh Pik Pin; Ministry Of Health Malaysia; gohpp@moh.gov.my;  +6013 3336822

 

Source: WHO Joint News Release

Communication Updates by CRM (updated 6th May 2020)

 

 

 

Ensuring Effective Financial Management in Sponsored Research in Malaysia

The principles of developing, conducting, analysing and subsequently reporting clinical research are widely known.1- 3 However, the success of a clinical trial goes beyond these principles. It also requires a structured, viable and businesslike management of the whole process, without which trials may fail.4 A critical part of managing clinical trials is a solid, well thought out clinical trial budget.5 A successful budget to ensure a good quality clinical trial should not only entail careful detailing of costs that are in line with the trial protocol, but should also include a financial management system that executes this budget in an efficient, timely and transparent manner.

Some issues and challenges in formulating clinical trial budgets could be applicable when managing the finances during conduct of the trials. Examples include how to maintain audit trails and being abreast of billing processes, ensuring all costs have been encountered for, and management of residual monies. Though ultimately the responsibility of the principal investigators, the detailed construction of a clinical trial budget and its management places a huge burden on physicians (or researchers) who have to juggle clinical practice while overseeing the running of multiple clinical trials.

Reducing the Burden of Principal Investigators

Established in 2012, the main objectives of Clinical Research Malaysia (CRM) are to effectively increase the speed, reliability and quality in delivery of outcomes of clinical trials conducted within the country. This is in line with the Malaysian government’s vision to enhance the country’s placing among other clinical trial hubs as a preferred global destination for clinical research.6 CRM, therefore, is also equipped to manage the financial aspects of clinical trials and is currently used extensively by principal investigators, investigators, contract research organisations (CRO) and sponsors conducting clinical trials in Ministry of Health facilities.

CRM’s financial management services extend throughout the trial process, i.e. from prior to study initiation to its close. Legal services are also included during the initial process to support the management of clinical trial agreements (CTAs), parallel with negotiations and refining of the trial budget. CRM reviews and endorses the study budget for the CTA within seven working days (from the last feedback date received from the relevant party involved in the budget negotiation). CRM takes on full financial and administrative duties that include initial budget negotiation with sponsors/CROs and investigators, keeping track of the trial progress, budget and invoicing, receipt of funds from sponsors/ CROs and payments to various stakeholders involved. CRM also prepares statements of account for the principal investigators on a monthly basis to facilitate better planning of clinical trial activities.

Facilitating Initiation of Clinical Trials

Involvement of the finance team starts just prior to initiation of the clinical trial in collaboration with the legal department, principal investigators, CROs and sponsors. This is crucial, as CROs, sponsors and investigators each bring expertise required for the conduct of specific types of trials, whilst the finance team contributes with their experience working on the financial aspect of clinical trials across the board. The legal team facilitates the process by ensuring that the CTA meets local requirements. The finance team also supports CROs, sponsors and investigators when negotiating and finalising the trial budget with approval from these parties. The timeframe for this process is expedited by a dedicated team handling the details of the negotiations and preparation of the approved final budget for submission, though it is still dependent on response time from CROs, sponsors and investigators.

Financial Management During Trial Conduct

CRM’s involvement in the management of the clinical trial budget is to reduce payment time through a standardised financial process by prompt issuing of invoices and providing efficient disbursements of payments. This ensures that the financial management of clinical trials conducted by investigators at their respective clinical trial sites has a proper audit trail and is executed in an efficient and transparent manner.

Prior to the establishment of CRM, all financial transactions to and from government linked facilities were routed via established local medical societies or the clinical research arm of the Ministry of Health (Clinical Research Centre). Between 2012 and March 2015, payments to investigators had to go through a trust account under the purview of the Director of Kuala Lumpur Hospital. Due to red-tape processes, payments could take at least a month.

However, from April 2015, CRM’s role expanded to making payments out directly to investigators and study team members (specifically government-employed staff affiliated with Ministry of Health facilities) and similarly reduced the timelines to within two weeks. With the advancement of online banking facilities in Malaysia, these timelines have further reduced. In 2018, the total value of trial budget managed by CRM was RM 39.5 million, compared to 2015 which was only about RM8.3 million, translating to more than four times in the growth of the budget management.

In addition, CRM’s responsibilities encompass ensuring there are enough funds available for the smooth running of a clinical trial by keeping track of the budget and communicating with sponsors so that payments are as scheduled in the trial budget and CTA. If, for any undue reasons, receipt of funds from sponsors is delayed, CRM steps in to guarantee timely payments to vendors and study subjects, ensuring that trials are on track. All receipts and disbursements of funds are carefully tracked, and monthly statements of account are sent to the principal investigators for review. All financial processes performed by CRM are also audited by internal and external auditors, which include the National Audit Department and the Ministry of Health. During the close of a trial, CRM provides an added service of negotiating the best price for archiving trial-related documents from third-party vendors. This enables cost savings in a clinical trial budget as well as more efficient conduct during clinical trial study closure.

Conclusion

CRM in essence acts as an account manager with in-house expertise in clinical trial budget management. Its focus is to streamline the processes for all clinical trials conducted in Ministry of Health facilities and involving Ministry of Health staff. CRM facilitates the clinical trial process from the budget negotiation stage, receipt and disbursement of study funds and lastly, archiving services upon study closure.

Audrey Ooi (Acting Head Business of Development) and Yau Yit Huan (Head of Finance & IT) are from Clinical Research Malaysia.

REFERENCES

1. European Medicines Agency. ICH Topic E8: General considerations for clinical trials – Step 5 (CPMP/ICH/291/95). March 1998.

2. National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia. Malaysian guideline for good clinical practice. Fourth edition. 2018.

3. Chew BH. Planning and conducting clinical research: the whole process. Cureus 2019;n(2): e4n2. DOI: 10.7759/cureus.4n2.

4. Farrell B, Kenyon S, Shalmr H. Managing clinical trials. Trials 2010;11:78. Available at http://www.trialsjournal.com/content/n/1/78. Accessed October 2019.

5. Hatfield E, Dicks E, Parfrey P. Budgeting, funding and managing clinical research projects. In: P. Parfrey and B. Barrett, editors. Methods of Molecular Biology, Clinical Epidemiology, vol. 473. Totowa, New Jersey: Humana Press, 2009; 299-3n.

6. Ooi AJA, Khalid KF. Malaysia’ clinical research ecosystem. Applied Clinical Trials 2017. Available at http://www.appliedclinicaltrialsonline.com/malaysia-s-clinical-research-ecosystem. Accessed October 2019.

Source : Journal for Clinical Studies

Access to Biological Resource and Benefit Sharing Act 2017(Act 795) Malaysia : Legal Opinion on the Implementation of the Act to the Clinical Trial Industry and its Negative Impacts

The Act was announced by Natural Resources and Environment Ministry to be implemented in Malaysia in 2017. It was aimed to regulate the use of biological resources, addresses issues of biopiracy and ensures that result benefits from the access of biological resources are shared equitably. Its content is mainly to conserve and reserve the biodiversity ecosystem in Malaysia for instance, conservation of natural resources like plants, animals but also included the access to human genetic resources. Access to human genetic resources will surely impacted the Clinical Trial Industry in Malaysia. As Clinical Research Malaysia is a company owned by the Ministry of Health Malaysia where we act as a one stop center for Clinical Trial Industry (“the Industry”) in Malaysia we opined that the implementation of the Act will have several negative impacts in the Industry as such our intention in writing this article is to inform the industry and also the relevant parties as to why similar Act should not be implemented to Clinical Trial Industry be it in Malaysia or other countries and how this is actually has been curbed through the initiative taken by Clinical Research Malaysia.

The Act sets out the requirements for access to Biological Resources or Traditional Knowledge associated with Biological Resources for research and development activities[1] whereby the implementation of the Act is to protect the use and access of Biological Resources in Malaysia. Whereas, Clinical Trial is a scientific study that prospectively assigns or conducted on human participants or groups of humans to one or more health-related interventions as a mean to treat, prevent, diagnose or manage various medical condition or diseases[2] and also to evaluate the effects on health outcomes, the inventions may include but are not restricted to drugs (investigational products), devices, surgical procedures,  cells and other biological products, radiological procedures, behavioral treatments, preventive care and others[3]. It is human rights that one should have the access to health care.   Enforcing the Act to the Clinical Trial Industry would add more steps and more guidelines for a Clinical Trial or Study to be conducted in Malaysia which may lead to the delay in completing the Clinical Trial and may further lead to the depletion of Clinical Trial in future.

Obtaining Permit under this Act

Under the Act, any local or foreign individual or corporation who intends to access Biological Resources or Traditional Knowledge associated with Biological Resources for commercial, or potentially commercial or non-commercial purpose must obtain a permit, violation of this application of permit may cause the relevant party to be penalized. However, a permit may not be  required for any research and development activity that is under a public higher education institution, research institution or Government agency within Malaysia, the exchange of Biological Resources between persons within a public higher education, institution, public research institution or Government agency within Malaysia or the access is by any person outside Malaysia or in a private institution within Malaysia from a permit holder who possesses a valid permit to access for the purpose of carrying out or continuing any research for non-commercial purpose[4]. Under the Act, in order to have access to biological resources and to obtain a permit to access biological resources,  the accompanying documents required to be submitted along with an application for a permit is the Prior Informed Consent which has to be obtained from Indigenous local community,  organization, resource provider or their representative and Benefit Sharing Agreement that has to be entered into with the resource provider who gave access to the Biological Resources or Traditional Knowledge. A Benefit Sharing Agreement under the Act is described as a legally binding contract entered between the person who intends to access the resources or traditional knowledge relating thereto with the resource provider and shall be based upon mutual agreed terms and provide a fair and equitable benefit sharing [5].

Benefits in Protecting Our Natural Resources!!

In our humble opinion, we do agree that the implementation of this Act may bring a lot of benefit in protecting our natural resources but not when it comes to conducting Clinical Trial which is a solution to provide a better healthcare and medicine to Malaysian citizen. The contention on our stand to oppose the application of the Act to the Industry is substantiate on few comprehensive measures currently exist in Malaysia to regulate and control Malaysian Clinical Trial Industry. First, conducting Clinical Trial in Malaysia already have their own guidelines that spells out the procedures in conducting Clinical Trial or Study such as the Good Clinical Practice guidelines.  Second, to regulate and oversee the Clinical Trial or Study conduct as well as to approve the application of import license or exemption of the investigational product/drug, the regulatory body/authority like the National Pharmaceutical Regulatory Agency (NPRA) plays a significant role. Third, the presence of Medical Research and Ethics Committee (MREC) that approves the trial, are sufficient enough as all the protocol, procedures of the Clinical Trial have been examined carefully and thoroughly by the said authority/regulatory body to ensure that it is safe, ethical and further comply with all the requirements and guidelines in conducting Clinical Trial [6]. Fourth, as patients’ consent is the utmost consideration before enrolling them as Clinical Trials subjects, their rights are protected and respected where prior to Clinical Trial is being conducted, informed consent must be obtained from the patients[7].  Legally speaking, the law on contract has evolved as a framework to regulate voluntary exchange transaction. Informed Consent is a voluntary agreement to participate in research. It is not merely a form that is signed but is a process, in which the subject understands the research and its risks. Informed consent is essential before enrolling a participant and ongoing once enrolled. Informed Consent obtained from the patients prior to enrol them as the participating subjects in the Clinical Trial is sufficed to reflect the voluntariness of patients. In Malaysia, the Clinical Trial Informed Consent Form (ICF) shall be reviewed by the ethics committee where the committee itself is comprises of medical background members and lay members. This is crucial as the ICF need to be worded in a layman term so that the patients will not be misled or participating out of undue influence.

The Clinical Trial Agreement (CTA) and its Impact

Fifth, before conducting the Clinical Trial, the relevant party also must have entered into a legally binding agreement known as Clinical Trial Agreement (CTA) which manages the relationship between the Sponsor that may be providing the device or study drug, the financial support and /or proprietary information; the Institution that may be providing data facilities, and/or results; the Principal Investigator and the Study Team that are responsible to conduct the Clinical Trial. The CTA also would describe and acknowledge responsibilities of the relevant party, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms,  guidelines for dispute resolution, and also terms to ensure the patients’ rights and  rights of all the parties  who involved in the Study are protected such as indemnification, insurance, subject injury /adverse event clauses[8]. As such the Benefit Sharing Agreement proposed by the Act is certainly not relevant to the Industry.

Sixth, implementing the Act in Clinical Trial Industry,  will reduce the number of Clinical Trial or Study and also may further delay any Clinical Trial or Study to be conducted in Malaysia as the Industry/ Sponsor must now obtain permit from the relevant authority and enter into benefit sharing agreement with a resource provider and further adhere to additional requirements and procedures which double up the existing procedure and requirements of Clinical Trial in Malaysia (i.e. Informed Consent Form, Clinical Trial Agreement, existing approval from regulatory bodies).Besides that, it may also decrease the innovation in medical industry in providing and improvise the procedure, techniques, medicine and device to be utilised by the patient in Malaysia to provide a better solution to cure their diseases and providing better healthcare. In other words, the patient would be jeopardised from getting alternative treatment/medicine that could prolong their lives. In fact, the implementation of the Act could also reduce the intangible value of research in sharing technology with other countries , recognition from the world for conducting a quality , reliable trial and expanding resources in order to introduce a better treatment, medicine, therapies, procedure and devices to the patient in Malaysia. It is worth to note that any benefits resulting from the Clinical Trial and its applications should be shared with society as a whole and with the global community. The benefits may take in various forms which includes but not limited to giving special and sustainable assistance to and acknowledgement to those that have taken part in the Clinical Trial or Study, public access to quality health care, access to scientific and technological knowledge, building up facilities for research purpose and any other forms of benefit consistent to the above.

Clinical Research Malaysia (CRM) Views

Clinical Research Malaysia (CRM) viewed that, it is best for every Clinical Trial that is to be conducted in Malaysia and other countries to be exempt from the implementation of this Act or any similar Act considering the benefits of it to the country and the people and further due to the adherence of this industry to the fundamental principles, requirement and regulatory compliance and relevant authority in conducting the Clinical Trial or Study in Malaysia. Further, CRM also actively involved in discussing with the relevant authorities in Malaysia on the negative effects of the implementation of the Act to the Clinical Trial Industry. It is a good action that the enforcement body and authorities in Malaysia now support the rights of the people to participate in Clinical Trial and to receive a better healthcare service and medicine by finally giving exemption to the Clinical Trial from the implementation of the Act commencing 2019 .

 

Nurul Atiqah Abd Rahman (Senior Legal Executive), Siti Nuralis Abd Muis & Siti Nur Hafizah Adnan (Legal Executives) are from Clinical Research Malaysia’s Legal Department

 

References:

[1] Section 5 of the Access to Biological Resources and Benefit Sharing Act 2017(Act 795)

[2] Australian Government National Health and Medical Research Council, Department of Innovation, Industry and Science. (2015, April 8). Retrieved from Australian Clinical Trial: https://www.australianclinicaltrials.gov.au/what-clinical-trial  (2019, June 11)

[3] Health Topics, Clinical Trials. Retrieved from World Health Organization: https://www.who.int/topics/clinical_trials/en  (2019, June 11).

[4] Section 18 of the Access to Biological Resources and Benefit Sharing Act 2017(Act 795)

[5] Section 22 of the Access to Biological Resources and Benefit Sharing Act 2017(Act 795)

[6] A Guide to Conducting Clinical Trials in Malaysia. (2016). Society of Clinical Research Professionals Malaysia

[7] Malaysian Guideline for Good Clinical Practice. (2018). National Committee for Clinical Research (NCCR), National Pharmaceutical Regulatory Agency (NPRA).

[8] Centre for Clinical and Translational Science. Retrieved from https://ccts.osu.edu/content/clinical-trial-agreement (2019, 11 12)

 

Source: InfoMed Magazine

Attracting Clinical Research to Malaysia with a Centralized Feasibility Platform

A feasibility study is a crucial part of the clinical trial planning process. It enables sponsors and contract research organizations (CROs) to identify relevant clinicians who may be interested in a particular study.1-4 It also provides information on a site’s infrastructure, human resources and pool of eligible patients.1-4 Such information would help these companies strategize to meet timeliness, sample size requirements and regulatory and ethical conditions, as well as plan for potential challenges.

As clinical research involves multiple stakeholders, the presence of a single point of contact can improve communication, simplify processes, and reduce delays.5,6 This centralized approach is particularly useful for feasibility and site selection processes.6 In Malaysia, Clinical Research Malaysia (CRM), a not-for-profit government-owned organization established in 2012 to nurture an ecosystem that supports industry sponsored research in the country, offers sponsors and CROs a one-stop contact point for feasibility requests, access to the public hospital network of investigators, and other services.

This review will present the role of CRM’s centralized feasibility service in attracting sponsors and CROs to Malaysia.

 

 The importance of rigorous feasibility studies

Pre-feasibility is information that is collected for preliminary, higher level assessments which allows sponsors and CROs to make decisions at a national and global level. Such enquiries include general questions on standard of care, drug registration status, epidemiology, and estimated patient pool of a particular therapeutic indication. A full feasibility study is a complete documentation of individual sites which may include a confidential disclosure agreement, protocol synopsis and site assessment questionnaire.

About 35% of delays in clinical trials are attributed to patient recruitment with one in five investigators unable to recruit a single patient.4 As non-active or under-performing trial sites can increase the cost of conducting a clinical trial by 20% or more,7 rigorous feasibility studies conducted in multiple centres are recommended.8 But conducting thorough feasibility assessments and selecting appropriate sites may be time consuming, and delay in these preliminary processes will jeopardise study milestones.7 Therefore, if feasibility processes in individual countries can be centralized with a single point of contact for sponsors and CROs, delays and redundancies may be avoided.5,6

 

Leveraging the strength of a nationwide access to public hospitals

One of the challenges in conducting feasibility studies is maintaining an updated database of principal investigators. The bulk of studies in Malaysia are conducted in government hospitals where doctors are transferred periodically. Therefore, data built on individual company databases can be outdated, thus misguiding and delaying feasibility approaches.

In Malaysia, CRM is the common link for various stakeholders which include sponsors, CROs, private and public doctors from universities, health clinics and hospitals, as well as the regulatory agencies and ethics committees. It is a centralized government-owned body that manages and overlooks Malaysia’s entire clinical research ecosystem.9 The detailed objectives of CRM are discussed in a prior article.10

As a single point of contact for sponsors and CROs and with presence in 33 clinical research centres within public hospitals throughout the country, CRM is vital in streamlining and accelerating feasibility studies in Malaysia.

 

Evolving to offer complimentary, centralized feasibility management

As CRM receives a variety of enquiries (Table 1) including pre-feasibility and full feasibility requests across all clinical therapeutic areas from both sponsors (pharma, medical device, biotech) and CROs worldwide, the Ministry of Health, Malaysia through CRM, established a centralized feasibility service. This service which is offered complimentary to sponsors and CROs, capitalizes on a comprehensive updated internal database of investigators, and enables outreach to a wider range of investigators and sites.

Previously, the sponsors and CROs conducted their own feasibility assessments and contacted individual sites on their own.11 Separate databases based on a company’s own experience, may not always be updated, and information such as transfer of clinician, changes in site personnel, and regulatory changes may be missed.11

A centralized process leads to centralized knowledge of the research environment which benefits CROs and sponsors engaging the service. A central database which incorporates data on a site’s performance and experience in recruitment and compliance provides more insight into how the site may perform in future trials.1,7 And as a single point of contact, the standardized processes lead to streamlined communications which reduces delay and confusion on the ground. As a result, the turnaround time is shorter than if a sponsor or CRO were to approach individually.

As CRM has a strong network, good rapport with investigators, and is familiar with ground level capacities of sites, poor site selection is less likely. Sites are mapped according to disease to enable the right sites to be approached for a specific patient pool in future. The sites are also mapped to track investigators who were overwhelmed, conducting competing trials, or transferred to ensure that only available investigators are contacted for upcoming trials. Such data would help narrow down the investigators who will give positive responses, thus reducing the time needed for feasibility studies.

When the feasibility team at CRM receives a feasibility questionnaire, a thorough analysis based on CRM’s central intelligence database is done (Figure 1). The questionnaire is then forwarded to relevant investigators. The process from the time CRM is approached to conduct a full feasibility assessment to the time CRM sends the completed questionnaire back to the company would take 5–10 working days. Pre-feasibility enquiries would take between one and five days depending on the complexity of the questions.

In addition, the feasibility specialists help interested potential investigators to address the queries and submit the completed feasibility questionnaire to the enquiring company. They provide technical consultation and organize meetings between investigators and CROs. Information is also compiled when investigators reject feasibility requests to understand their reasons for doing so.

 

Centralized service, a key attraction for sponsors and CROs 

A centralized feasibility management service is a key attraction for sponsors and CROs,5 as the information from feasibility studies determines the suitability of Malaysia for a particular trial and promotes the capability of the sites to new international companies. The one-stop national feasibility model improves efficiency and timelines, as well as reduces the financial, administrative, and human resource burden of sponsors, CROs and investigators.

Sponsors and CROs are becoming more interested in Malaysia after the introduction of centralized feasibility, with full feasibility requests received by CRM increasing between 2015 and 2018 (Figure 2). There were also a five-fold increase in sponsors and an almost three-fold increase in CROs using CRM’s services in 2018 compared to 2014 (Figure 3). Majority of these companies are international companies (85%).5,11

In addition, feasibility assessments are complimentary, thus contributing to the overall cost-effectiveness of conducting a trial in Malaysia.

 

Conclusion

Clinical Research Malaysia’s model as a one-stop national center is a primary factor for the expansion in Malaysia’s clinical research industry in the last few years. The growth in sponsors and CROs is made possible through a centralized feasibility team coordinating and overseeing communications with sites. Thus, on a nationwide perspective, a centrally managed feasibility structure is an attractive alternative for sponsors and CROs looking to enhance efficiency and width of a feasibility outreach, avoid redundant processes and promote a more accurate assessment of Malaysia’s capabilities.

 

Noorzaihan Mat Radi (Senior Feasibility Specialist), Dr. Tan Bee Ying (Feasibility Specialist) and Audrey Ooi (Acting Head of Business Development)  are from Clinical Research Malaysia.

 

References

  1. Johnson, O. An Evidence-Based Approach to Conducting Clinical Trial Feasibility Assessments. Clin. Invest. (Lond.). 5(5), 491–499 (2015).
  2. Orsmond, G.I. & Cohn, E.S. The Distinctive Features of a Feasibility Study: Objectives and Guiding Questions. OTJR. (Thorofare N J). 35(3), 169–77 (2015).
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Source: Journal for Clinical Studies

I Am Aware Photography Series Launch and Exhibition at Ministry of Health, Putrajaya

PUTRAJAYA, 19 December 2019 – The Ministry of Health aims to improve and provide better health care in the country by supporting the clinical research industry as well as in promoting participation in clinical trials.

Clinical trials which are largely funded by global pharmaceutical, medical device and biotechnology companies brings various innovative treatment options to clinical trial participants. Patients who participate in clinical trials receive either a promising new treatment or the best available conventional treatment. Especially in the area of cancer treatment, clinical trials have been proven to offer some of the most effective cancer treatments currently available today.

These clinical trials are often been misconstrued as experimental testing on patients despite the significant impact made on improving medical treatments. The misconception continues with the public’s limited understanding due to the lack of exposure on clinical trials.

The Health Ministry seeks to correct these misconceptions as well as improve the awareness of clinical trials among Malaysians. Through its corporatized entity, Clinical Research Malaysia (CRM), the I AM AWARE Photography Series collections were developed to raise the profile of clinical trials among patients and the general public in the country.

The Photography Series launched by the Secretary General of the Ministry of Health, YBhg Dato’ Seri Dr. Chen Chaw Min, on behalf of the Health Minister, features a photo collection of real-life patients that have participated in a clinical trial. It portrays the different stages of a clinical trial patient’s life, sharing their experience before and after participation. “Malaysia is an ideal clinical trial site because it has an adequate and efficient healthcare system with a strong pool of highly qualified medical professionals, consistent start-up timeline, competitive trial cost and strong commitment from the MOH that maintains the quality and integrity of clinical trials in our country. I hope that with this initiative, more Malaysians will understand the innovative treatments brought about by clinical trials and can make better informed decisions”, said YBhg Dato’ Seri Dr. Chen during the launching of the ceremony.

In order to reach wider audiences at the national level, mobile exhibition roadshows as well as instilling awareness through this photography series collection will be touring the country at major public and private hospitals from next year onwards to engage with patients. The photography series, comprising of stand-alone panels and booklets, showcases the core part of clinical trial which is the unsung heroes that have contributed to research that may improve medical treatments and advance medical science.

 

 

 

 

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